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Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.

INCB001158

Epacadostat at the protocol-defined dose administered orally twice daily.

Epacadostat

Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.

Sven Gogov, MD

The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.

A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors

An Open-Label, Multicenter, Nonrandomized, Dose-Escalation, and Tumor-Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat (INCB024360), With or Without Pembrolizumab, in Subjects With Advanced Solid Tumors

TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment.

Defined as percentage of subjects having a complete response (CR) or partial response (PR) based on investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Defined as percentage of subjects having a CR or PR based on investigator assessment per RECIST v1.1.

Defined as percentage of subjects having CR, PR, or stable disease for at least 56 days based on investigator assessment per RECIST v1.1.

Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.

Defined as the time from date of first dose of study treatment until the earliest date of disease progression (based on investigator assessment of per RECIST v1.1) or death due to any cause, if occurring sooner than progression.

Noncompartmental method of analysis will be used to analyze the plasma concentrations of INCB001158 and epacadostat.

Incyte Corporation

The safety population included all subjects enrolled in the study who received at least 1 dose of study treatment.

INCB001158 dosed at 50mg BID in combination with epacadostat (100 mg BID) and pembrolizumab (200 mg Q3W)

INCB001158 50mg BID+ Epacadostat + Pembrolizumab

INCB001158 dosed at 75mg BID in combination with epacadostat (100 mg BID)and pembrolizumab (200 mg Q3W)

INCB001158 75 mg BID + Epacadostat + Pembrolizumab

Total

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

No patients were analyzed due to insufficient numbers and risk of identifying patient by reporting data on 1 person enrolled in cohort 2

Study Director

Phase 1 Only: Safety and Tolerability of INCB001158 in Combination With Epacadostat ± Pembrolizumab as Assessed by Number of Participants With a Treatment-emergent Adverse Event (TEAE)

Data was not collected as no participants were enrolled in Phase 2 of the study

Spots Global Cancer Trial Database for arginase 1 inhibitor